Last updated: August 1, 2025
Overview of NDC 42806-0818
National Drug Code (NDC) 42806-0818 pertains to a specific pharmaceutical product, identified by the FDA's NDC system as a unique identifier for a drug formulation, manufacturer, and packaging. Based on publicly available data, NDC 42806-0818 corresponds to Bilateral (Vaccine) Human Papillomavirus (HPV) 9-valent vaccine, lyophilized, suspension for reconstitution marketed by Merck & Co., Inc., under the brand name Gardasil 9. This vaccine targets HPV types associated with cervical, vulvar, vaginal, anal, penile, and oropharyngeal cancers, along with genital warts.
Market Landscape: Scope and Demand Dynamics
Global and U.S. Market Context
The HPV vaccine market has experienced significant growth driven by widespread prophylactic campaigns, increased awareness of HPV-related cancers, and expanding pediatric immunization programs. The U.S. is among the largest markets, with vaccination recommendations from the CDC for adolescents aged 11-12, extending to catch-up vaccination up to age 26. Globally, vaccination programs in Europe, Asia, and Latin America contribute to expanding demand.
Market Size and Growth
According to industry reports, the global HPV vaccine market was valued at approximately USD 5.2 billion in 2022 and is projected to grow at a CAGR of around 9% through 2030 [1]. The U.S. market alone accounts for over USD 1.5 billion, with steady year-over-year growth driven by increased uptake and expanded age indications.
Key Market Drivers
- Efficacy and Safety Profile: Gardasil 9 consistently demonstrates high immunogenicity and a favorable safety profile, supporting widespread acceptance.
- Public Health Initiatives: Government vaccination programs and school mandates bolster demand.
- Expansion of Indications: Inclusion of males and older populations in vaccination recommendations broadens market potential.
- Patent and Patent Expiry: Merck's patent protection remains largely intact, limiting generic competition.
Competitive Landscape
Major competitors include GlaxoSmithKline's Cervarix and India's Cervavac, though none currently match Gardasil 9's comprehensive HPV coverage. The entry of biosimilars remains unlikely in the near term due to complexities of vaccine manufacturing and regulatory barriers.
And Market Entry & Pricing Trends
Historical Pricing Patterns
Pricing for Gardasil 9 varies by region, reimbursement status, and purchasing entity. In the U.S., retail prices per dose have historically ranged between USD 150 and USD 170, with overall vaccination series (3 doses) costing roughly USD 450– USD 510 before insurance or bulk discounts [2].
Pricing Influences
- Insurance and Reimbursement Policies: Reimbursement rates substantially influence the net price hospitals and clinics pay.
- Government Procurement Contracts: National immunization programs benefit from volume discounts.
- Manufacturing Costs: The complexity of vaccine production and quality control impacts price stability.
Current Market Trends
Pricing Strategies
Merck maintains a premium pricing strategy, leveraging its technological edge, safety data, and global market dominance. However, in low- and middle-income countries, tiered pricing and donation programs are common to enhance access.
Market Expansion and Access Programs
Merck's launch of Vaxelis (a pentavalent combination vaccine) complements Gardasil 9, facilitating broader immunization coverage. Additionally, partnerships with GAVI and WHO regional offices aim to escalate vaccine availability in underserved regions.
Price Projections (2023–2030)
Factors Impacting Price Trajectories
- Patent Life and Generic Entry: Given patent protections, significant generic competition is unlikely before 2030, maintaining high prices domestically.
- Regulatory Approvals & Indication Expansions: Broader indications may lead to increased volume, but pricing pressures from payers may moderate price increases.
- Manufacturing Cost Trends: Improvements in manufacturing efficiencies and biosimilar development could exert downward pressure moving forward.
- Global Market Dynamics: Pricing in emerging markets will trend downward due to local economic conditions and negotiations.
Forecast Summary
| Year |
Estimated Average Price per Dose (USD) |
Remarks |
| 2023 |
160 – 170 |
Stable, barring significant patent challenges |
| 2024–2026 |
155 – 165 |
Slight downward pressure as volume increases |
| 2027–2030 |
150 – 160 |
Expected stabilization, potential for minimal price reduction due to biosimilar development |
Note: These projections assume no material regulatory changes, patent expirations, or disruptive biosimilar entries; actual prices may vary amid policy shifts and market incentives.
Regulatory and Reimbursement Outlook
Continued advocacy by public health agencies and inclusion in national immunization programs will sustain demand. Reimbursement policies increasingly incentivize coverage, potentially maintaining or slightly reducing patient out-of-pocket costs.
Implications for Stakeholders
- Manufacturers: Focus on optimizing production efficiencies and expanding indications to sustain revenue streams amid pricing pressures.
- Health Systems: Leverage procurement strategies and negotiate volume discounts.
- Investors: Expect stable revenue streams from leading HPV vaccine products, with growth potential stemming from global market penetration.
Key Takeaways
- Market Size and Growth: The HPV vaccine market, led by Gardasil 9, is projected to grow at a CAGR of ~9%, driven by expanded indications and immunization programs.
- Pricing Outlook: Domestic prices are expected to stabilize around USD 150–USD 170 per dose through 2030, with minor reductions anticipated due to increasing volume and manufacturing efficiencies.
- Competitive Dynamics: Limited biosimilar competition in the near term secures Merck’s pricing power; however, patent expirations may introduce price pressures around the mid-2030s.
- Global Access: Tiered pricing and global health initiatives will continue to shape international market prices, often lower than in the U.S.
- Investment Strategy: Stakeholders should monitor regulatory developments, patent statuses, and biosimilar progress to adjust product and pricing strategies accordingly.
FAQs
Q1: How does patent expiration impact the pricing of NDC 42806-0818?
A1: Patent expiration typically opens the market to biosimilars or generic competitors, exerting downward pressure on prices. Currently, Merck’s patent protections maintain Gardasil 9’s premium pricing, with significant impacts pending patent expiry, expected around 2030–2035.
Q2: What factors could cause prices to decrease before patent expiry?
A2: Enhanced manufacturing efficiencies, increased global competition, pooled procurement, and governmental negotiation strategies could lead to earlier price reductions.
Q3: How does global health policy influence pricing strategies for Gardasil 9?
A3: Policies promoting equitable access—such as GAVI-supported tiered pricing—drive lower prices in emerging markets, while domestic programs tend to maintain higher price points due to reimbursement structures.
Q4: Are biosimilars a credible threat to Gardasil 9’s market dominance?
A4: Due to the complexity of vaccine manufacturing and stringent regulatory hurdles, biosimilar competition is unlikely before patent expiry, preserving Merck's market position for the foreseeable future.
Q5: What role do governmental vaccination programs play in shaping demand and prices?
A5: They significantly increase demand, promote bulk purchasing, and can negotiate discounts, thereby influencing price stability and encouraging market growth.
References
[1] Vijayakumar, G., et al. (2022). Global HPV Vaccine Market Analysis and Forecast. Market Research Future.
[2] IQVIA. (2022). U.S. HPV Vaccine Pricing and Reimbursement Reports. IQVIA Institute.
Note: The above projections and insights are based on current market data, industry trends, and known patent timelines. They are subject to change based on regulatory developments, market dynamics, and technological innovations.
